- Bezuclastinib cut total symptom scores by 8.91 points more than placebo at 24 weeks in the SUMMIT trial.
- 87.4% of treated patients saw ≥50% drop in serum tryptase levels, versus 0% in the placebo group.
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Cogent Biosciences, Inc.‘s COGT bezuclastinib showed meaningful clinical benefit for patients with non-advanced systemic mastocytosis, a rare and debilitating immune disorder.
With statistically significant improvements across all endpoints—including symptom reduction and biomarkers of mast cell activity—the data support the company's plan to file for Food and Drug Administration approval by the end of 2025.
The results not only validate Cogent's targeted approach but also position bezuclastinib as a potential first-in-class therapy for a condition with limited treatment options.
Systemic mastocytosis (NonAdvSM) is a rare disease characterized by the abnormal accumulation of mast cells in various tissues, including the bone marrow, skin, and other organs.
The latest study demonstrated meaningful and highly statistically significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden.
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Based on these data, Cogent is on track to submit its first new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvSM by the end of 2025.
In addition, Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year.
The SUMMIT trial achieved its primary endpoint with a statistically significant difference in the mean change in total symptom score (TSS) at 24 weeks.
The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm, which had a mean reduction of 15.4 points, resulting in a placebo-adjusted TSS improvement of 8.91 points.
In addition, the SUMMIT trial demonstrated statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which 87.4% of bezuclastinib-treated patients had ≥50% reduction, compared to no patients in the control arm (87.4% vs. 0%).
Complete analysis of the full SUMMIT Part 2 data is ongoing, and Cogent plans to present detailed results at a major medical conference later this year.
Cogent remains on track to provide topline results from both PEAK, a Phase 3 trial of bezuclastinib in combination with sunitinib in patients with gastrointestinal stromal tumors, and APEX, a registration-directed trial of bezuclastinib in advanced systemic mastocytosis patients, during the second half of 2025.
The company has a cash balance of $237 million and access to an additional $350 million via a recently announced debt facility with SLR Capital Partners.
Price Action: At the last check on Monday, COGT stock was up 15.7% at $8.77 during the premarket session.
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